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Food And Drug Administration Warning Diet Pills

What is FDA?

The US FDA or Food and Drug Administration is a government’s regulatory agency under the Department of Health and Human Services. It is tasked with regulating the commerce of prescriptive and non-prescriptive medication, pharmaceutical products, foods and processed food products, veterinary products, radiation-emitting products, vaccines and cosmetic products.

It does the same thing for medical devices, hospital and healthcare products, tobacco products as well as controlling the interstate and clearance of transported drugs and food stuff from other countries.

Weight loss or diet pills may fall either as food supplements or drugs. Most weight loss solutions in the market are marketed as diet food supplements and therefore require no prior FDA approval before they are marketed. The FDA mandate to regulate dietary supplements is stipulated in the Dietary supplement health and Education Act of 1994 which treats diet supplements as food rather than as drugs. Makers of these supplements are free to claim health benefits confined to the structure or function of their products. But because the FDA does not perform any testing, they are required by law to display a disclaimer on their labels, ads or websites to the effect that their product endorsements have not been FDA-evaluated and that their claims are not intended to diagnose, treat or prevent any disease.  

In addition, the FDA released a regulatory guideline called CGMPs or Current Good Manufacturing Practices which has regulatory compliance requirement for food processing and diet supplement manufacturing.  

FDA Evaluation On Diet Pills

But diet pills that are categorized as drugs may be subject to FDA evaluation and approval in terms of their efficacy as claimed, the right dosage and side effects. The Center for Food Safety and Applied Nutrition is the entity under the FDA that is responsible for ensuring the safety and labeling accuracy of all food and drugs marketed in the US.

A weight loss drug, like any drugs, can be classified as prescriptive or over-the-counter (OTC). In general, all newly manufactured drug brands are required to undergo FDA testing and approval under an NDA (New Drug Application) prior to being commercially produced and marketed.

Once approved, they start out as prescriptive drugs. An FDA-approved drug means it is “safe and effective when used as directed.” Over time, many prescriptive drugs now deemed safe can be approved by the FDA as OTC drugs.  

In addition, the FDA has around 300 approved chemical ingredients that combine to produce about 100,000 OTC drugs. Its OTC Monograph defines the dosage, labeling and warnings for drugs considered as "GRASE" (Generally recognized as safe and effective to be exempted from applying as a new drug for approval. Weight loss drugs that conform to this need not secure NDA testing and evaluation which is an expensive and time-consuming process.

The FDA regularly issues press releases to inform and warn the public against tainted weight loss drugs and supplements that it had confirmed based on its analyses to contain undeclared pharmaceutical ingredients that endanger consumer health.

Check out the FDA site listing 72 dieting products it is seeking market withdrawal here:

source: www.fda.gov/newsevents/newsroom/pressannouncements/ucm149547.htm

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